BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES

    MDR report key: 562238 · Received December 15, 2004

    Report

    Report Number
    562238
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    October 19, 2004
    Report Date
    December 15, 2004
    Manufacturer
    SYNTHES USA INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INITIAL INTERNAL FIXATION WAS OBTAINED WITH A SEVEN-HOLE 3.5-MM SMALL FRAGMENT ONE-THIRDTUBULAR FIXATION PLATE. THE PATIENT WENT ON TO HEAL UNEVENTFULLY AND OBTAINED EXCELLENT FUNCTIONAL USE OF THE HAND BUT HAD NOT YETRETURNED TO WORK. THE PATIENT PRESENTED TO CLINIC A FEW MONTHS POSTOPERATIVELY WITHOUT SYMPTOMS, BUT WITH X-RAY EVIDENCE OF HARDWARE FAILURE THROUGH ONE OF THE SCREW HOLES, WITH EVIDENCE OF HYPERTROPHIC NONUNION OF THE ULNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES SMALL FRAG PLATE HRS SYNTHES USA INC 4526172 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR